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Standard Operating Procedure  For Handling Of Returned Products

by Pharmadocx Consultants

PURPOSE:  To lay down the procedure and methods to handle the product returned to

warehouse for any reason, its disposition, responsibility for implementation of the

procedure and records to be maintained.

RESPONSIBILITY  :

The Commercial Officer.

The Quality Assurance Officer.

The Production Manager.

PROCEDURE:       

1.  Isolate the returned products in a restricted area and identify indicating the details of

the consignment and reason for return.

2.  Inform the quality assurance department to assess whether the consignment is to be destroyed or reprocessed for distribution or sale.

3.Classify the returned product on basis of:

a)  Date expired product.

  • Damaged or broken primary container
  • Multilated or smudged labeling of its name or batch number.
  • Soiled labeling rendering the product un-salable or un-presentable on the shop shelves but otherwise identifiable.
  1. Take authorisation in writing from quality assurance department for destruction of:
    • The date expired product
    • Unidentifiable product
    • Product with damaged or broken primary container
    • Product unsuitable for redressing.
  2. Carry out the destruction under supervision of committee comprising quality assurance, production and commercial department personnel.
  1. Empty out the contents of individual containers of product to be destroyed.  Collect the content in a vessel containing water.  Label the vessel.  Drain in mains before effluent treatment plant.
  • Obliterate the printing on printed packaging material and crush.

Written by Anmol Singh

Anmol Singh Completed his Bachelors in Field of Mechanical and Automation Engineering. He has over 2 Years of experience in field of Pharmaceuticals, Medical Devices, Cosmetics Manufacturing.

13 June 2023

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